C.E.S. TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-09-2020
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ingredients actius:
CONJUGATED ESTROGENS
Disponible des:
BAUSCH HEALTH, CANADA INC.
Codi ATC:
G03CA57
Designació comuna internacional (DCI):
CONJUGATED ESTROGENS
Dosis:
0.625MG
formulario farmacéutico:
TABLET
Composición:
CONJUGATED ESTROGENS 0.625MG
Vía de administración:
ORAL
Unidades en paquete:
100/1000
tipo de receta:
Prescription
Área terapéutica:
ESTROGENS
Resumen del producto:
Active ingredient group (AIG) number: 0106442006; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2020-09-23
Fitxa tècnica
PRODUCT MONOGRAPH
PR
C.E.S.
Conjugated Estrogens Tablets, CSD
0.625 mg
ESTROGEN
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 23, 2020
Laval, Quebec
H7L 4A8
Control No.: 242944
_Pr_
_C.E.S._
_®_
_ Product Monograph Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................24
DETAIL
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